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It is largely invented and based on the skewed interpetation of the authors who want us to believe that their misleading and sloppy scholarship is less lethal than smoking. I am not sure myself and I hate smoking…
Here are the conclusions three of the studies they used to make this sweeping conclusion:
A thoughtful and provocative piece by Matt Herper over at Forbes.
FDA Agreement Should Be Public
One of the biggest initiatives Margaret Hamburg has announced since she became head of the Food and Drug Administration is a new push to make FDA's doings more transparent to the outside world. Yesterday's bad news for Seattle-based Cell Therapeutics represents one way in which the regulator fails to make sure investors have information they need.
Cell Therapeutics (CTI) shares fell 40% to 60 cents yesterday after an briefing document prepared by the FDA raised multiple problems with the company's drug, pixantrone, and the quality of the clinical trials Cell Therapeutics is using to argue for its approval as a treatment for non-Hodgkin's Lymphoma. The biggest shocker, though, related to an agreement called a "special protocol assessment" which the company had told investors it had but which the FDA now says is no longer valid.
Special protocol assesments, or SPAs, are important for every drug company, from the tiniest fleaspeck biotechnology company all the way up to Pfizer. They are agreements between a company and the FDA that a clinical trial, if conducted as planned and successful, should produce enough data for a drug to be approved. This reassures companies that they are not going to pour $40 million into a late-stage study only to have the FDA say it did the wrong trial. SPAs also ease investor fears, helping smaller companies raise money.
Unfortunately, they are treated by FDA as confidential communications between the agency and companies. What is said to investors about the SPA is entirely up the the company. Between March 28, 2008, and September 16 2009, CTI reference the SPA in five press releases. But in the briefing documents released yesterday, the FDA stated: "On March 28, 2008, CTI notified the FDA of an early halt to enrollment for PIX301. The study was not stopped at a planned interim analysis and early study stopping invalidated the applicant’s Special Protocol Assessment." A CTI spokesman did not comment when asked why investors were not informed of this change.
This is not the first time this sort of thing has happened. In 2008, it was revealed at an FDA advisory committee meeting that GPC Biotech had misrepresented the SPA for its prostate cancer drug, causing shares to drop 60% in a day.
It might take an act of Congress to allow the FDA to make SPAs public, but that should happen. This would increase their value to biotechnology firms who are trying to raise money and prevent run-of-the-mill stock buyers from getting fleeced.
EJ Dionne the doyen of liberal lecturing down to the masses explains -- through a charming parable told to him by a member of Congress -- why it is ok for Democrats to ram through the current health bill -- Cornhusker kickback and all: because we the dumb schmucks are too stupid to understand what's good for us until it is put in front of us in the fashion liberals have established:
"On health care: 'Finish the kitchen'
By E.J. Dionne Jr.
Monday, February 8, 2010; A15
If President Obama gets to sign a health-reform bill, as I believe he will, one reason may be Rep. Jay Inslee's difficult experience renovating his kitchen.
He told his kitchen story at a House Democratic caucus after Republican Scott Brown's victory in Massachusetts sent Inslee's colleagues into paroxysms of dismay, chaos and fear. Brown's triumph reduced the Democrats' majority in the Senate to "only" 59, and this led many in both houses to want to give up on health reform altogether. Even Obama was sounding an uncertain trumpet.
This made no sense to Inslee, a Democrat from Washington state. First elected to the House in 1992, he was swept out of office in the 1994 Republican landslide that followed the collapse of Bill Clinton's health-care efforts. Four years later, Inslee returned to Congress.
"I introduced myself as a fella who was defeated in 1994, the last time we didn't pass meaningful health-care reform," Inslee recalls saying. "I said it was a painful event, and I didn't want them to go through that pain." In politics, he told his colleagues, assuming the "fetal position" can be the most dangerous thing to do.
And then he recounted all the grief he and his family went through while work on their kitchen renovation dragged on and on and on. "During that time, I had blood lust against my contractor," Inslee said. "Six months went by, and he was still arguing with the plumber. Eight months went by, and there were still wires hanging down everywhere, and he was having trouble with the building inspector."
But eventually, the job got done. "And now I love that kitchen," Inslee recalls saying. "I bake bread in that kitchen. My wife cooks great meals in that kitchen. The contractor's now a buddy of mine, and I've had beers with him in that kitchen."
Inslee looked at his colleagues and declared: "We've got to finish the kitchen." His point was that Americans won't experience any of the benefits of health-care reform until Congress puts a new system in place.
I called Inslee about his kitchen oration after Rep. David Wu (D-Ore.) told me it was one of the turning points in calming Democrats' nerves. "Now," Wu says, "people run into him in the hallway, smile and say, 'Finish the kitchen.' "
Dionne is in LOVE with this analogy... I hope he and his fellow autocrats continue to spread the message.
Here's how is condescending disregard for the public sounds to the rest of us simple folk:
"Some paradox of our natures leads us, when once we have made our fellow men the objects of our enlightened interest, to go on to make them the objects of our pity, then of our wisdom, ultimately of our coercion. " Lionel Trilling, The LIberal Imagination (1950)
Apart from the dangerous and bizaare indulgence of the whims of anti-vaccine and anti-science groups, AHRQ's role in developing studies and evidence standards for use of personalized medicine, targeted therapies, nanotechnology, drug/diagnostic combinations, etc.. (studies conducted by a small group of organizations that include those controlled by HMOs who also control the funding decisons made by AHRQ) for HMOs, Medicare, Medicaid, etc will impose significant costs on innovation and well-being.
Most recently the FDA approved the use of Crestor as a preventive treatment for heart disease using hsCRP tests to identify those specific patients who might benefit. Clearly a step towards targeted and prudent use of statins. Women were found to benefit more than men from early intervention. Yet ARHQ's recommendation to the US Preventive Services Task Force was to NOT use hsCRP tests in primary care settings until there were more randomized trials..
Continuing to impose the barrier of randomized trials on all new individualized technologies is tantamount to creating Jim Crow laws for personalized medicine. And indeed, the impact of using expensive randomized trials to test everything new will be to make fewer new things available without knowing which are valuable to who.
Which is the point of bending the curve: slowing consumption of new technologies across the board to free up money for bigger entitlements. Unfortunately, the use of older and cheaper more often does not translate into better health and lower costs.
Republicans and Democrats who truly want a serious American effort to improve health care should shun the White House offer of media exposure and concentrate on getting better information on what my colleague Peter Pitts calls the four health care rights of the 21st century: the right medicine for the right person for the right reason at the right time. Such rights increase wellbeing and improve value. Scrapping AHRQ's agenda and conflicted approach to pursuing it is the first step in that healthy direction
The Pink Sheet Reports:
Gaining the expertise and infrastructure needed to assess products of the future - such as biosimilars and those based on stem cells and nanotechnology - is the goal of a $25 million scientific modernization effort proposed in the fiscal 2011 FDA budget.
The Advancing Regulatory Science Initiative (ARSI) is a cross-center program whose ultimate objective is to provide FDA scientists with the skills to evaluate the safety, effectiveness and quality of products developed with new and emerging technologies, as well as give industry the standards by which such products will be judged.
The agency bills the initiative as the first major effort to address a 2007 FDA Science Board report that cited FDA's inability to keep up with scientific advances, such as those in biology and bioinformatics.
The Center for Drug Evaluation and Research plans to "establish regulatory guidance to provide a scientifically sound and safe pathway to better characterize and develop biosimilars," the agency says in supporting documentation for its budget.
ARSI, which FDA characterizes as a new program and an increase in budget authority, provides $2 million for the biosimilar effort. Another $3.7 million in carry-over balances from user fees will be used for the program.
As part of a $15.55 million increase for infrastructure, workforce and collaboration, ARSI includes money to prepare for reviewing products that utilize stem cells and nanotechnology.
With the removal in 2009 of the ban on federal funding for embryonic stem cell research, FDA "anticipates a significant increase in investigational new drug applications and biologics license applications for stem cell products during the next few years," the agency says.
In anticipation of that, ARSI gives the Center for Biologics Evaluation and Research $950,000 and five full-time equivalents to prepare for reviewing stem cell products (i.e., a therapy comprised of, or derived from, human cells, tissues or cellular or tissue-based products, and gene therapy products) as novel biologic therapies.
The FY '11 funds will allow CBER to develop and communicate guidance that provides agency expectations for pre-clinical studies, clinical trial design and regulatory policy. CBER also will work with the scientific community to develop analytic tests for characterizing stem cell products.
The largest chunk of ARSI is $7.3 million for nanotechnology regulatory science across the agency. CBER and CDER each will receive $475,000 and one FTE to participate in the effort.
The intent is to build laboratory testing capacity, develop and train staff in nanotechnology and conduct research into the character and safety of products. The latter will help FDA scientists as they review the benefits and risks of products, such as drugs delivered by nanoparticles to cancer cells.
Included in ARSI is a $4.45 million increase in funding for the Critical Path Initiative. The money will enable FDA to launch new projects for validating biomarkers, modernize and increase the efficiency of clinical trials; improve tools to predict product safety and effectiveness, including the use of information technology; and modernize toxicology studies.
FDA's documents do not provide a baseline figure for CPI, but includes it under the Office of the Chief Scientist (OCS), which is budgeted at a total of $29.59 million. Funding for CPI in the current fiscal year is $16 million.
The money also will enable OCS to staff the Office of Science and Innovation, which is being set up to serve as a core resource of scientific expertise in emerging areas. OSI was created in a reorganization implemented by Commissioner Margaret Hamburg in mid-2009 to improve the agency's scientific capabilities.
Back in August Amphastar was so unsatisfied with the way the FDA was dealing with their file for generic Lovenox, they decided to claim unfair treatment at the hands of CDER Director Dr. Janet Woodcock.
Amphastar claimed that its rival, Momenta, had a "leg up" and was getting "special access." And yet both companies were in the same place in the regulatory process and both companies are being asked for the same data sets. And this is unfair why?
According to Amphastar it's unfair because CDER Director, Dr. Janet Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.
Well, to nobody’s surprise, the inspector general of the Department of Health and Human Services has cleared Janet of all allegations of conflict of interest.
Not satisfied to acknowledge a boner of monumental proportions, Amphastar's general counsel, Jason Shandell, said that the FDA narrowly tailored its review to legal issues. "We never asserted she got any money—that would be illegal. Our focus was on the appearance of impropriety and its impact on the approval system.”
Yeah, right.
Talk about desperate measures.
http://spectator.org/archives/2010/02/05/woe-is-ahrq
The Right Prescription
Woe Is AHRQ
This week the British medical journal Lancet officially retracted an already discredited article it published by Andrew Wakefield which falsely claimed vaccines caused autism. (See how the journal was shamed into doing the right thing here.)
At the same time, President Obama increased the budget of the Agency for Healthcare Research and Quality (AHRQ) -- charged with developing information about what are the best and most cost-effective medical treatments -- by $640 million, including money for anti-vaccine groups who regard Wakefield as a hero and push studies examining the effectiveness of treatments and diets based on Wakefield's study for reversing or curing autism.
AHRQ is the same agency that provided the United States Preventive Services Task Force (USPSTF) the data for recommending women under the age of 50 not get a regular mammogram. Before every major health group rejected the decision, the administration said the guideline was based on the "best available science."
Mentioned twelve times in the health bill, AHRQ states its goal is "translating research into improved health care practice and policy. " In fact, AHRQ was and is the administration's go-to agency for "bending the healthcare cost curve." Hence, in 2009 AHRQ's budget increased from $300 million to $1 billion for "comparative effectiveness research" (CER): studies looking at two or more treatments or a diagnostic for the same disease to see if one delivers equal or better results for the same amount of money. The studies would be used to create government guidelines for hundreds of medical treatments like the mammogram decision.
Proponents claim that CER helps doctors make better "patient-centered" decisions instead of one-size fits all recommendations. But AHRQ spends all its money making comparisons based on research -- as it did in producing the study recommending against routine mammography for women under 50 -- that ignores individual differences in patients.
So, for instance, in reviewing the "science" of mammography, AHRQ ignored "differences in outcomes among certain risk subgroups, such as women with BRCA1 or BRCA2 genetic susceptibility mutations, women who are healthier or sicker than average, or black women who seem to have more disease at younger ages than white women." As a result, the study only provided "estimates of the average benefits and harms."
That's why Nobel Prize winner and NIH Director Francis Collins who helped map the human genome worries that CER studies are a step backwards because they consider "everybody equivalent, which we know they are not." Collins says that CER -- and AHRQ by extension -- fails to use "all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies."
Meanwhile AHRQ allows CER researchers to hand out money to each other.
For instance, Dr. Alan M. Garber of Stanford University has received millions of dollars of AHRQ grants over the years and is a member of member of AHRQ's panel for determining what evidence should be packaged into guidelines. Garber also advises Congress on what AHRQ should spend money on. HMO's also happen to operate CER research centers that get much of AHRQ's funding.
Dr. Mark Helfand -- who contributed research to the mammogram decision -- runs the Oregon Health & Science University Drug Effectiveness Review Project that receives millions from AHRQ each year. Helfand also directs AHRQ's "science" board for its CER program.
Sean Tunis, another AHRQ consultant also advised Congress on the AHRQ agenda. Tunis once said he never saw adequate evidence to justify paying for new medical technology.
AHRQ's involvement with anti-vaccine groups is also longstanding. It has given millions a year to Consumers United for Evidence Based Care (CUE) an organization that "advocates for local and federal legislative changes," in favor of CER. CUE includes groups like the Center for Science in the Public Interest and the National Center for Trangender Health. The anti-vaccine groups SAFEMINDS and the National Vaccine Information Center are also active parts of CUE.
CUE participants use CER to push their own political agenda with AHRQ help. In 2005 CUE coordinator Dr. Kay Dickersin (another AHRQ grant recipient) and transgender advocacy groups challenged Washington State's Medicaid program decision not to cover sex change operations. SAFEMinds used CER to claim that you couldn't rule out vaccines "causing" autism.
And now AHRQ is funding the NVIC/SAFEMINDS pet project that looks at the effectiveness of controversial and dangerous autism treatments such as chelation therapy, which have killed several children.
Given the deficit, AHRQ's budget should be cut, starting with is funding of outdated science, transgender advocacy and anti-vaccine movements. That would insure CER actually improved the public health.
You’ve certainly heard the old business saw, “Only half of my advertising works – now if I only knew which half.”
Now consider something of infinitely greater importance – government spending on healthcare.
Next year government programs will account for more than half of all dollars spent on U.S. healthcare spending. By 2020 about one in five dollars spent in the U.S. will go to health care.
Public funds accounted for 47% of the $2.34 trillion of national health spending in 2008, the last year for which figures are available. CMS estimates, in a paper to be published Thursday in the journal Health Affairs, that the proportion will rise to 50.4% by 2011.
Are we spending too much – or are we not spending it in the right way?
Much debate over what “too much” is – but very little argument that we need to spend more smartly. What does “smartly” mean? There’s the rub. Well, for starters, it must mean getting patients (aka “people”) on the best, most effective therapies as quickly as possible. It doesn’t mean forcing physicians to “fail first” on less expensive options. That’s not only contrary to the public health, it’s pernicious to the public purse. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.
When it comes to healthcare spending and healthcare reform, we’d do well to remember the words of Winston Churchill:
“There are a terrible lot of lies going around the world, and the worst of it is half of them are true.”
Which “half” indeed?
Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her, um, enthusiastic comments about a yet-to-be-approved anti-wrinkle injectable.
At first blush this seems like regulatory creep and cause for First Amendment agita. But it isn’t. This is not a case of the FDA trying to stifle unregulated speech by an individual without “interest.” Dr. Bauman is a clinical investigator for the product she’s been touting. That’s “interest” whether the trial sponsor paid her to do so or not. (In this instance, there was no “pay for play.”) In any case, it’s an unambiguous regulatory no-no.
According to FDA regulation (at 21 CFR 312.7(a)), "A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug."
No ambiguity there. No regulatory creep. Just good enforcement in an area of medicine that is all too frequently prone to hyperbole. This is not (IMHO) about the free and fair dissemination of scientific data -- or even an "interested" discussion thereof.
Alas, just as too many medical marketers misinterpreted the agency’s April 2009 letters on sponsored Google links to mean “we can’t use social media,” so too will many pharmaceutical MLR departments ( the “nabobs of no”) point to the Bauman letter as a reason to question the appropriate use of medical spokespeople. And the New York Times certainly does stoke the flames of such paranoia in its reportage. (See New York Times story here.)
My advice, read the letter before you get your panties in a twist about “doctors are being muzzled” or overly agitated that the FDA is getting ready to launch a full-frontal assault on physicians-as-spokespeople. Just read the regs – and stay away from the gray zone.
Good catch DDMAC.
January 29, 2010 Statement by the National Vaccine Information Center on Dr. Andrew Wakefield and his research
The National Vaccine Information Center (NVIC) supports the past, present and future scientific research into the reported association between inflammatory bowel disease, developmental delays and vaccination in young children conducted by Dr. Andrew Wakefield and other physician scientists. Dr. Wakefield’s work to define the pathogenesis and etiology of chronic inflammation in the body that can affect brain and immune function is commendable. His work has led to biomedical interventions for children, who have become chronically ill and disabled after vaccination, to ease their suffering.
Research to better define the association between vaccination and chronic inflammatory disorders that affect brain and immune function should be given a much higher priority by government, industry and academia. Understanding the biological mechanisms for vaccine induced chronic inflammation in children and adults can help identify those at high risk for suffering vaccine reactions, injury and death and lead to adoption of safer vaccine policies.
http://www.the-scientist.com/community/posts/list/0/846.page
"The Lancet today retracted a 1998 study by Andrew Wakefield and colleagues that, based on a sample of 12 children, claimed to have found a link between autism and the widely used MMR (measles, mumps, and rubella) vaccination. The paper induced a long string of correspondences published in the journal and stirred major controversy surrounding the vaccination.
10 of the paper's 13 authors had already acknowledged some of the problems with the paper, publishing a "retraction of an interpretation" in 2004. But the official retraction didn't occur until today, as a result of the Britain's General Medical Council's finding against Wakefield and two of his colleagues, who are at risk of losing their rights to practice medicine in Britain for their "unethical" methodology, and for describing the research in a "dishonest" and "irresponsible" way.
Given the fallout of the paper's claims, including a drop in vaccinations and a resurgence of measles, what measures must now be taken? Is a simple retraction enough, or is a published re-analysis of the data with a more accurate interpretation of the results necessary? Is losing their medical licenses in Britain a harsh enough punishment for Wakefield and his colleagues, or are more severe actions required?"
--Jef Akst, Associate Editor, The Scientist
Consumers United for Evidence-based Healthcare (CUE) is a national coalition of health and consumer advocacy organizations committed to empowering consumers to make the best use of evidence-based healthcare (EBHC). CUE, organized in 2003 when the USCC invited advocacy groups to join a consumer advocate-scientist partnership, is a pioneering effort to improve consumers’ ability to engage in and demand high quality healthcare.
Currently, the 27 member organizations represent: cancer, geriatrics, temporomandibular joint disorders, minority health, addiction, environmental health, lesbian, gay, bisexual, and transgender health, mental health, women’s health, and disabilities. The Coalition is committed to a representative membership that addresses the needs of AHRQ’s priority populations. As a result, CUE is an educated, diverse, and committed advocacy network.
CUE is a consumer advocate-scientist partnership.
Initial funding from the Agency for Healthcare Research and Quality (AHRQ) has enabled the USCC to nurture CUE’s development and to provide a secretariat and staff. CUE is guided by an elected Steering Committee providing overall direction and policy and program development.
CUE Member Organizations:
- Annie Appleseed Project http://www.annieappleseedproject.org/
- Black Women’s Health Imperative http://www.blackwomenshealth.org/
- Center for Medical Consumers http://www.medicalconsumers.org/
- Center for Science in the Public Interest http://www.cspinet.org/
- Cherab Foundation http://www.cherab.org/
- Childbirth Connection http://www.childbirthconnection.org/
- Citizens for Health http://www.citizens.org/
- Citizens Health Alliance for Truth http://www.chatdc.org/
- Consumers Union http://www.consumersunion.org/
- Faces and Voices of Recovery http://www.facesandvoicesofrecovery.org/
- Lamaze International http://www.lamaze.org/
- Mautner Project, the National Lesbian Health Organization http://www.mautnerproject.org
- National Breast Cancer Coalition http://www.natlbcc.org/
- National Center for Transgender Equality http://www.nctequality.org/
- National Coalition for Lesbian, Gay, Bisexual and Transgender Health http://www.lgbthealth.net/
- National Consumers League http://www.nclnet.org/
- National Council on Aging http://www.ncoa.org/
- National Environmental Education & Training Foundation www.neetf.org/
- National Mental Health Consumers’ Self-Help Clearinghouse www.mhselfhelp.org/
- National Partnership for Women & Families www.nationalpartnership.org/
- National Vaccine Information Center www.909shot.com/
National Vaccine Information Center www.909shot.com/
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
